UMIN-CTR Clinical Trial

Basic information
Public title	Recording communication data of autism spectrum disorder and schizophrenia
Acronym	Recording communication data of autism spectrum disorder and schizophrenia
Scientific Title	Recording communication data of autism spectrum disorder and schizophrenia
Scientific Title:Acronym	Recording communication data of autism spectrum disorder and schizophrenia
Region	Japan Europe

Condition
Condition	autism spectrum disorder and schizophrenia
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Social skills are the ability to manage verbal and non-verbal behavior during a conversation. People who have difficulty in interacting with others struggle to properly manage their social behavior and interpret them. Social Skills Training is a well-founded method developed to train social interaction. In this study, we will collect data on how the subject and the trainer are conducting individual SST. Analyzing the verbal and non-verbal social skills of the subject and trainer from the recorded data of autism spectrum disorder and schizophrenia. The purpose of this study is to develop a system that can train social skills using virtual agents.
Basic objectives2	Others
Basic objectives -Others	Evaluate verbal response dialogue patterns, non-verbal timing, intentions, phonemes, facial expressions, gestures
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Verbal response dialogue pattern, non-verbal timing, intention, phoneme, facial expression, gesture
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	6 years-old <=
Age-upper limit	50 years-old >
Gender	Male and Female
Key inclusion criteria	Autism spectrum disease between 6 and under 16 Autism spectrum disorder and schizophrenia between 20 and under 50
Key exclusion criteria	intellectual disabilities, drug and alcohol abuse, personality disorders, or brain disorder
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Yasuhiro Middle name Last name Matsuda
Organization	Nara Medical University School of Medicine
Division name	department of Psychiatry
Zip code	6348522
Address	840 Shijo-cho, Kashihara, Nara
TEL	0744-22-3051
Email	yasumatsuda319@hotmail.com

Public contact
Name of contact person	1st name Yasuhiro Middle name Last name Matsuda
Organization	Nara Medical University School of Medicine
Division name	department of Psychiatry
Zip code	6348522
Address	840 Shijo-cho, Kashihara, Nara
TEL	0744-22-3051
Homepage URL
Email	yasumatsuda319@hotmail.com

Sponsor
Institute	Nara Medical University School of Medicine
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Heartland Shigi Nara Institute of Science and Technology Centre national de la recherche scientifique
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nara Medical University School of Medicine
Address	840 Shijo-cho, Kashihara, Nara
Tel	0744-22-3051
Email	smuraka@naramed-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 03 Month 05 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2019 Year 12 Month 18 Day
Date of IRB	2019 Year 12 Month 18 Day
Anticipated trial start date	2020 Year 03 Month 05 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We aim to build a computer dialogue system that reflects SST.

Management information
Registered date	2020 Year 03 Month 05 Day
Last modified on	2020 Year 03 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043895